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 Failure to Advance (2524); Material Split, Cut or Torn (4008)

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

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported failure to advance was unable to be replicated in a testing environment due to the condition of the returned device.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 determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after sheath and stylet removal inadvertent mishandling resulted in the noted tip damages (kinked, torn) thus resulting in the reported failure to advance over the guide wire.Manipulation of the device likely resulted in the noted stretched guide wire exit notch and the noted multiple hypotube bends.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during an intervention, the 3.0x18mm xience proa stent delivery system (sds) tip was noted to be restricted and could not be advanced over a guide wire.There were no reported adverse patient effects.There was no reported clinically significant delay in the procedure.Another unspecified device was ultimately used successfully to complete the procedure.Product return analysis revealed that there was a tear 2.5mm proximal to the distal tip.

Manufacturer Narrative

The device was returned for analysis.The reported failure to advance was unable to be replicated in a testing environment due to the condition of the returned device.The distal tip of was kinked and torn.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 determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after sheath and stylet removal inadvertent mishandling resulted in the noted tip damages (kinked, torn) thus resulting in the reported failure to advance over the guide wire.Manipulation of the device likely resulted in the noted multiple hypotube bends.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device code.Added h10: addtl mfg narrative.

• 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
• MDR Report Key: 12357210
• MDR Text Key: 267824020
• Report Number: 2024168-2021-07393
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2023
• Device Catalogue Number: 1128300-18
• Device Lot Number: 0112641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1