INNOVA
Report
- Report Number
- 2134265-2020-14575
- Event Type
- Injury
- Date Received
- October 22, 2020
- Date of Event
- October 2, 2020
- Report Date
- June 17, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIP
- PMA / PMN Number
- P140028
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
A1: PATIENT IDENTIFIER: (B)(6). E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER ADDRESS 1: (B)(6).
DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION WAS PERFORMED: THE DEVICE HAS KINKS IN THE BODY OF THE GUIDEWIRE LOCATED APPROXIMATELY AT 37.5CM AND 92CM FROM THE PROXIMAL END. THE RETURNED GUIDEWIRE WAS NOT COMPLETE, ONLY A SECTION WAS RETURNED. THE REMAINING PORTION OF THE DISTAL TIP WAS NOT RETURNED FOR ANALYSIS. MICROSCOPIC INSPECTION REVEALED THAT THE DISTAL TIP DETACHMENT CONFIRMED, A PORTION OF APPROXIMATELY 0.5 INCH OF DISTAL TIP WAS DETACHED AND NOT RETURNED. DIMENSIONAL INSPECTION REVEALED THAT THE OVERALL LENGTH, OUTER DIAMETER (OD) DISTAL, OD MEDIUM, OD PROXIMAL WERE WITHIN SPECIFICATION. ALTHOUGH OVERALL LENGTH IS WITHIN SPECIFICATION, A PORTION OF 0.5 INCH OF THE DISTAL TIP OF THE GUIDEWIRE IS DETACHED AND NOT RETURNED AND O.D. DISTAL MEASUREMENT COULD NOT BE PERFORMED DUE TO DEVICE CONDITION (DISTAL TIP DETACHED AND NOT RETURNED). PICTURES WERE PROVIDED BY THE CUSTOMER AND MEDIA INSPECTION WAS PERFORMED AND REVEALED THE ROTAWIRE WAS WITHIN ITS PROTECTIVE HOOP, NO DAMAGES OBSERVED. THE DISTAL TIP OF THE GUIDEWIRE WAS DETACHED AND MISSING, ADDITIONALLY, SOME FOREIGN MATERIAL COVERING THE DISTAL END, PROBABLY FROM THE PROCEDURE. THE SOLDER WELD OF THE TRANSITION AREA WAS COVERED BY THE SAME FOREIGN MATTER. THE DISTAL TIP OF THE GUIDEWIRE DETACHED AND MISSING AND THE REMAINING PORTION COVERED BY THE SAME FOREIGN MATTER.
IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE EMINENT STUDY ON (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS. THE LESION WAS 50 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM AND WAS CLASSIFIED AS TASC II A LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF A 6 MM X 80 MM STUDY STENT. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED ON ANTIPLATELET THERAPY. ON (B)(6) 2020, THE SUBJECT VISITED SITE FOR PROTOCOL SCHEDULED 12 MONTH FOLLOW-UP VISIT. PER EDC, RUTHERFORD CLASSIFICATION WAS 0 (ASYMPTOMATIC) AND ABI RATIO WAS 0.94. DUPLEX ULTRASOUND PERFORMED ON THE SAME DAY REVEALED RESTENOSIS IN THE STENT OF LEFT SFA. ON (B)(6) 2020, THE EVENT WAS CONSIDERED RESOLVED WITH SEQUELAE. ON (B)(6) 2020, 378 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR PLANNED INTERVENTION OF THE TARGET LEG. ON THE SAME DAY, TARGET LESION WAS LOCATED IN LEFT MID SFA WITH 96% STENOSIS AND WAS 60 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 6 MM. IN-STENT RESTENOSIS IN THE LEFT SFA WAS TREATED WITH PERCUTANEOUS INTERVENTION USING DRUG ELUTING BALLOON. POST PROCEDURE REVEALED 20% RESIDUAL STENOSIS. ON (B)(6) 2020, THE EVENT 002 WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT AN ANGIOGRAPHY ON (B)(6) 2020, REVEALED 90% HIGH GRADE IN-STENT RESTENOSIS. SUBJECT ALSO NOTED MINIMAL SYMPTOMS OF CLAUDICATION ALONG WITH MILD CALF PAIN WITH INCREASED WALKING. IN-STENT RESTENOSIS IN THE LEFT SFA WAS TREATED WITH PERCUTANEOUS INTERVENTION USING 6MM X 80MM DRUG ELUTING BALLOON. POST PROCEDURE REVEALED 20% RESIDUAL STENOSIS. THE SUBJECT WAS RECOMMENDED FOR ASA 100MG DAILY FOR LONG TERM AND CLOPIDOGREL 75MG DAILY FOR 3 MONTHS. (B)(6) 2020, THE EVENT 002 WAS CONSIDERED RESOLVED AND WAS DISCHARGED ON THE SAME DAY.
IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE EMINENT STUDY ON (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS. THE LESION WAS 50 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM AND WAS CLASSIFIED AS TASC II A LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF A 6 MM X 80 MM STUDY STENT. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED ON ANTIPLATELET THERAPY. ON (B)(6) 2020, THE SUBJECT VISITED SITE FOR PROTOCOL SCHEDULED 12 MONTH FOLLOW-UP VISIT. PER EDC, RUTHERFORD CLASSIFICATION WAS 0 (ASYMPTOMATIC) AND ABI RATIO WAS 0.94. DUPLEX ULTRASOUND PERFORMED ON THE SAME DAY REVEALED RESTENOSIS IN THE STENT OF LEFT SFA. ON (B)(6) 2020, THE EVENT WAS CONSIDERED RESOLVED WITH SEQUELAE. ON (B)(6) 2020, 378 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR PLANNED INTERVENTION OF THE TARGET LEG. ON THE SAME DAY, TARGET LESION WAS LOCATED IN LEFT MID SFA WITH 96% STENOSIS AND WAS 60 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 6 MM. IN-STENT RESTENOSIS IN THE LEFT SFA WAS TREATED WITH PERCUTANEOUS INTERVENTION USING DRUG ELUTING BALLOON. POST PROCEDURE REVEALED 20% RESIDUAL STENOSIS. ON (B)(6) 2020, THE EVENT 002 WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT AN ANGIOGRAPHY ON (B)(6) 2020, REVEALED 90% HIGH GRADE IN-STENT RESTENOSIS. SUBJECT ALSO NOTED MINIMAL SYMPTOMS OF CLAUDICATION ALONG WITH MILD CALF PAIN WITH INCREASED WALKING. IN-STENT RESTENOSIS IN THE LEFT SFA WAS TREATED WITH PERCUTANEOUS INTERVENTION USING 6MM X 80MM DRUG ELUTING BALLOON. POST PROCEDURE REVEALED 20% RESIDUAL STENOSIS. THE SUBJECT WAS RECOMMENDED FOR ASA 100MG DAILY FOR LONG TERM AND CLOPIDOGREL 75MG DAILY FOR 3 MONTHS. (B)(6) 2020, THE EVENT 002 WAS CONSIDERED RESOLVED AND WAS DISCHARGED ON THE SAME DAY. IT WAS FURTHER REPORTED THAT ON (B)(6) 2020, THE SUBJECT NOTED MINIMAL SYMPTOMS OF CLAUDICATION ALONG WITH MILD CALF PAIN WITH INCREASED WALKING. AORTO-ARTERIOGRAPHY ON SAME DAY AT LEFT SFA REVEALED GOOD INFLOW IN THE UPPER SECTION OF THE STENT, THEN SHORT-STRETCH PRESENTATION OF A HIGH-GRADE STENOSIS, THEN NORMAL LUMEN AGAIN, PRESENTATION OF TWO ADDITIONAL STENOSIS, EACH IN THE STENT REGION. THE STENOSIS GRADE WAS AT 90%. DISTAL OF THE STENT THERE WAS THEN A NORMAL SITUATION WITHOUT STENOSIS (AE002). POST PROCEDURE, RAPID FEMOROPOPLITEAL OUTFLOW AS WELL AS TWO-VESSEL OUTFLOW AT THE LEFT LOWER LEG WERE NOTED.
(B)(6).
IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS. THE LESION WAS 50 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM AND WAS CLASSIFIED AS TASC II A LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF A 6 MM X 80 MM STUDY STENT. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED ON ANTIPLATELET THERAPY. ON (B)(6) 2020, THE SUBJECT VISITED SITE FOR PROTOCOL SCHEDULED 12 MONTH FOLLOW-UP VISIT. PER EDC, RUTHERFORD CLASSIFICATION WAS 0 (ASYMPTOMATIC) AND ABI RATIO WAS 0.94. DUPLEX ULTRASOUND PERFORMED ON THE SAME DAY REVEALED RESTENOSIS IN THE STENT OF LEFT SFA. ON (B)(6) 2020, THE EVENT WAS CONSIDERED RESOLVED WITH SEQUELAE. ON (B)(6) 2020, 378 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR PLANNED INTERVENTION OF THE TARGET LEG. ON THE SAME DAY, TARGET LESION WAS LOCATED IN LEFT MID SFA WITH 96% STENOSIS AND WAS 60 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 6 MM. IN-STENT RESTENOSIS IN THE LEFT SFA WAS TREATED WITH PERCUTANEOUS INTERVENTION USING DRUG ELUTING BALLOON. POST PROCEDURE REVEALED 20% RESIDUAL STENOSIS. ON (B)(6) 2020, THE EVENT 002 WAS CONSIDERED RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1183985 | INNOVA | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | BOSTON SCIENTIFIC CORPORATION | 26920 | 0020133561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R |