PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
Report
- Report Number
- 2024168-2023-14009
- Event Type
- Malfunction
- Date Received
- December 14, 2023
- Date of Event
- November 24, 2023
- Report Date
- January 26, 2024
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MGB
- UDI-DI
- 08717648235184
- PMA / PMN Number
- P960043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS. THE ROOT CAUSE OF THE REPORTED DIFFICULTIES AND THE SUBSEQUENT TREATMENTS ARE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, IT IS LIKELY AN INTERACTION WITH THE SECOND DEVICE CAUSED THE DAMAGE TO THE FIRST IMPLANTED SUTURE RESULTING IN A MATERIAL SEPARATION. FACTORS AFFECTING A DEVICE DAMAGED BY ANOTHER DEVICE INCLUDE BUT ARE NOT LIMITED TO, THE FIRST DEVICE SUTURE IS TOO LOOSE IN THE VESSEL, OR IF THE ROTATION OF EITHER DEVICE IS SUBOPTIMAL. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. B5: DESCRIBE EVENT OR PROBLEM CORRECTED FOR ADDITIONAL CLARITY. D4 - LOT NUMBER WAS UPDATED FROM 3073141 TO 3053043. D4: EXPIRATION DATE AND H4: MANUFACTURING DATE UPDATED AS A RESULT.
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PERCLOSE PROSTYLE DEVICE REFERENCED IN B5 IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.
IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROSTYLE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO A TO A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) INTERVENTIONAL PROCEDURE. THE FIRST SUTURE WAS DEPLOYED AND PREPLACED AS INTENDED. REPORTEDLY, DURING PLACEMENT OF THE SECOND PROSTYE SUTURE, THE DEVICE INTERACTED WITH THE FIRST SUTURE CAUSING THE SUTURE TO SEPARATE. THE SECOND SUTURE WAS PREPLACED AS INTENDED. THE SUTURE OF ONE NEW PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 16F, AND THE TEVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT SUTURE PLACEMENT IN THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A PROSTYLE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA AN 8F SHEATH HOLE PRIOR TO A TO A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) INTERVENTIONAL PROCEDURE. THE FIRST SUTURE WAS DEPLOYED AND PREPLACED AS INTENDED. REPORTEDLY, DURING PLACEMENT OF THE SECOND PROSTYE SUTURE, THE FIRST SUTURE SEPARATED (BROKE) AND WAS REMOVED. THE SECOND SUTURE WAS PREPLACED AS INTENDED. THE SUTURE OF ONE NEW PROSTYLE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 16F, AND THE TEVAR PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROSTYLE SUTURES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1769020 | PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM | SUTURE MEDIATED CLOSURE | MGB | ABBOTT VASCULAR | 3053043 | 08717648235184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |