WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
Report
- Report Number
- 2134265-2017-06255
- Event Type
- Injury
- Date Received
- June 21, 2017
- Date of Event
- January 1, 2016
- Report Date
- February 10, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2017028 FOR PRODUCT CODE NGV. ATTACHMENT: [2018-03 SUPPLEMENT 03 TO 2017-06 EXEMPTION E2017028 SUBMISSION_NGV_SERIOUS INJURY.XLSX]
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2017028 FOR PRODUCT CODE NGV. PLEASE SEE ATTACHED SPREADSHEET FOR SUPPLEMENT SUBMISSION DUE 30 AUGUST 2017. ATTACHMENT: [2017-08 SUPPLEMENT TO 2017-06 EXEMPTION E2017028 SUBMISSION_NGV_SERIOUS INJURY.XLSX]
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2017028 FOR PRODUCT CODE NGV. ATTACHMENT: [2017-11 SUPPLEMENT 02 TO 2017-06 EXEMPTION E2017028 SUBMISSION_NGV_SERIOUS INJURY.XLSX]
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2017028 FOR PRODUCT CODE NGV.
Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes;A00638042,,SI,52,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638043,,SI,54,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638046,,SI,59,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638049,,SI,44,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;,,,205,,,;A00638051,,SI,43,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638056,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638687,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638059,,SI,43,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638347,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00639034,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638053,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638691,,SI,1,WATCHMAN® Access System,728-UNK,2993;A00638413,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00639163,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638697,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638062,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638064,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638649,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638700,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638086,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638087,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638088,,SI,46,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638693,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638090,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638702,,SI,7,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638089,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638996,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638651,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638095,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638097,,SI,49,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638099,,SI,56,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638107,,SI,58,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638686,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638690,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638113,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639032,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638109,,SI,45,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638112,,SI,60,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;,,,59,,,;A00638694,,SI,92,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639062,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00639097,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00639060,,SI,1,WATCHMAN® Access System,728-UNK,2993;A00638069,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639027,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638115,,SI,50,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638116,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638120,,SI,1,WATCHMAN® Access System,728-UNK,2993;A00638118,,SI,15,WATCHMAN ® LAA Closure Device & Delivery System,WU2106,2993;A00638119,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2106,2993;A00638668,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638698,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;,,,44,,,;A00638040,,SI,2,WATCHMAN ® LAA Closure Device & Delivery System,WU2106,2993;A00638614,,SI,2,WATCHMAN® Access System,728-UNK,2993;A00638094,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00639017,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00639067,,SI,8,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638071,,SI,96,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;,,,54,,,;A00638073,,SI,47,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638114,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00639929,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639931,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00639055,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638077,,SI,25;29,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638683,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00639354,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638110,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00639317,,SI,1,WATCHMAN® Access System,728-UNK,2993;A00638574,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638041,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2106,2993;A00638643,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00639069,,SI,0;1;2,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00639107,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638045,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00639310,,SI,1,WATCHMAN® Access System,728-UNK,2993;A00639070,,SI,42,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638577,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638054,,SI,0;3,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638590,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00639056,,SI,12,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638055,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638581,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638058,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638060,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638068,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638033,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638571,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638034,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638572,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638036,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638580,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638600,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638601,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00639058,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638038,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638610,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638044,,SI,64,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638037,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638047,,SI,42,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638057,,SI,0;0;4,WATCHMAN® Access System,728-UNK,2993;A00638083,,SI,40,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638085,,SI,43,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638093,,SI,47,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638100,,SI,3,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638102,,SI,2;4,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638104,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638082,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638992,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638061,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638111,,SI,4,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638070,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639029,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638117,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638660,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638080,,SI,3,WATCHMAN® Access System,728-UNK,2993;A00638103,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00639031,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638081,,SI,6,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638596,,SI,1;8,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638348,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639037,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638091,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638096,,SI,44,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638101,,SI,12,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638067,,SI,4,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638597,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638105,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2106,2993;A00638656,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638106,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638065,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00639025,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638108,,SI,9,WATCHMAN® Access System,728-UNK,2993;A00638288,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639019,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638722,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638327,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639313,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638344,,SI,49,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638098,,SI,0;2,WATCHMAN® Access System,728-UNK,2993;A00639063,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00639175,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00639049,,SI,43,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;,,,,,WU2406,;A00638350,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638944,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638351,,SI,48,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638361,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638931,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638384,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638443,,SI,43,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638506,,SI,8,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638412,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;,,,208,,,;A00639148,,SI,1,WATCHMAN® Access System,728-UNK,2993;A00638442,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00639151,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638468,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00639152,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638507,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638404,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2106,2993;A00639147,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638074,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638390,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638448,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638445,,SI,46,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638451,,SI,4,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638346,,SI,7,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638354,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638364,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638932,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638366,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00639324,,SI,1,WATCHMAN® Access System,728-UNK,2993;A00638370,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638306,,SI,0,WATCHMAN ® LAA Closure Device & Delivery 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System,WU2106,2993;A00639156,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638492,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2406,2993;A00638084,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638986,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638353,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,727-UNK,2993;A00638733,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638363,,SI,34,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638933,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638936,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638494,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00639072,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639187,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638358,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638748,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638750,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638496,,SI,1,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00638708,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2106,2993;A00639165,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638503,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU2706,2993;A00639053,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00639178,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00639065,,SI,49,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00639180,,SI,1,WATCHMAN® Access System,728-UNK,2993;A00638313,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00638679,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638718,,SI,42,WATCHMAN ® LAA Closure Device & Delivery System,WU3306,2993;A00638495,,SI,0,WATCHMAN ® LAA Closure Device & Delivery System,WU3006,2993;A00639157,,SI,0,WATCHMAN® Access System,728-UNK,2993;A00638391,,SI,0,WATCHMAN ® LAA Closure Device & Delivery 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THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2017028 FOR PRODUCT CODE NGV.
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2017028 FOR PRODUCT CODE NGV.
THIS REPORT SUMMARIZES 1 SERIOUS INJURY. THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2017028 FOR PRODUCT CODE NGV. BSC ID (B)(4).
SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS SUPPLEMENTAL REPORT IS BEING FILED AFTER A RETROSPECTIVE REVIEW REQUESTED BY FDA TO INCLUDE CODES IN THE SUMMARY 3500A. DATE OF EVENT: UNKNOWN.
SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS SUMMARY REPORT REPRESENTS 227 PATIENTS. THERE IS ONE ROW FOR EACH PRODUCT INVOLVED. IF THERE WERE MULTIPLE PATIENT OUTCOMES, THOSE ARE LISTED AS MULTIPLE PATIENT CODES AND THE TTE LISTS THE DAYS FROM PROCEDURE WHEN THOSE PATIENT OUTCOMES WERE OBSERVED. (B)(4).
THIS REPORT SUMMARIZES 1 SERIOUS INJURY. THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2017028 FOR PRODUCT CODE NGV.
BOSTON SCIENTIFIC RECEIVED EVENTS AS PART OF THE LAAO/NCDR REGISTRY FOR THE WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICES, FALLING UNDER THE LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) REGISTRY OF THE AMERICAN COLLEGE OF CARDIOLOGY'S NATIONAL CARDIOVASCULAR DATA REGISTRY (NCDR). THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2017028. THIS SUPPLEMENTAL REPORT IS BEING FILED AS REQUESTED BY FDA TO INCLUDE PATIENT, DEVICE AND EVALUATION CODES IN THIS SUMMARY MARKER REPORT. THE DATA IS COLLECTED IN ORDER TO ASSESS WHETHER THE RATES OF SAFETY AND EFFECTIVENESS DURING EARLY COMMERCIALIZATION ARE CONSISTENT WITH PREMARKET FINDINGS. BECAUSE LAAOR DATA IS REDACTED BEFORE BEING TRANSMITTED TO BSC, THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED FOR THESE 227 PATIENTS. THESE EVENTS ARE MOST LIKELY DUPLICATES WITH POTENTIAL FOR NON-DEVICE RELATED ADVERSE EVENTS INCLUDED.
BOSTON SCIENTIFIC RECEIVED EVENTS AS PART OF THE LAAO/NCDR REGISTRY FOR THE WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICES, FALLING UNDER THE LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) REGISTRY OF THE AMERICAN COLLEGE OF CARDIOLOGY¿S NATIONAL CARDIOVASCULAR DATA REGISTRY (NCDR). THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2017028 FOR PRODUCT CODE NGV.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438902 | WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | 10371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |