MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1128250-28

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The xience proa is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the chipboard box and dispenser coil of a 2.5x28mm xience pro a stent delivery system were found to be kinked prior to use.No damage to the sterile packaging was noted, but the sterility of the device cannot be confirmed.The device was not used and there was no patient involvement.A new xience pro a was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the device was returned for analysis.The reported kinked coil confirmed.The reported sterility issue could not be confirmed as the foil pouch was opened when received for analysis.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 kinked chipboard box (sterility issue) and kinked coil.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8453357
• MDR Text Key: 139898186
• Report Number: 2024168-2019-02324
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Catalogue Number: 1128250-28
• Device Lot Number: 7081461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1