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

Catalog Number 1550300-15

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that while unpacking the device, the grey pouch was twisted and connected with the clear sterile pouch.They could not be separated and device sterility was not known.The device was not used and there was no patient involvement.No additional information was provided regarding this device issue.

Manufacturer Narrative

Internal file number - (b)(4).If follow-up what type, correction: mfr site-reg#.Evaluation summary: the device was returned for analysis.The reported packing issues and packaging damage were 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 similar incidents from this lot.The investigation determined the reported packaging issues and packaging damage appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• 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: 8664739
• MDR Text Key: 146979593
• Report Number: 2024168-2019-04344
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Catalogue Number: 1550300-15
• Device Lot Number: 9021541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2019
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1