MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1128300-18

Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported deformation due to compressive stress was confirmed.A review of the lot history record 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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported deformation due to compressive stress; however, factors that could contribute to shaft kink (deformation due to compressive stress) includes, but are not limited to, manufacturing damage, damaged during shipping, and product damage during handling by user during dispenser removal.Additionally, holes were found in both the inner and outer member consistent with guidewire and/or stylet damage.The noted damage was near the confirmed kink (deformation due to compressive stress).The account was contacted to inquire about the returned device condition; however, the physician indicated that he no longer could remember details about the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience pro a device is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that prior to use the 3.0x18mm xience proa proximal shaft was kinked.Another xience proa stent was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay.No additional information was provided.Per device analysis there were holes in the inner and outer member, 4cm proximal to the proximal balloon seal.

• Brand Name: XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12488003
• MDR Text Key: 271897891
• Report Number: 2024168-2021-08245
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Catalogue Number: 1128300-18
• Device Lot Number: 1021241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1