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

Catalog Number 1012648-38

Device Problems Difficult To Position (1467); Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

It was reported that during insertion of the 3.0x38 mm xience prime stent delivery system (sds) into the introducer sheath, the sds stuck, after which a stent strut was observed to be flared.The device never entered the patient.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.Returned goods analysis revealed a shaft tear.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The stent damage was unable to be confirmed; however the resistance with the introducer sheath was able to be confirmed.The distal end of the hypotube was sticking out of the distal shaft and the shaft was torn.Based on a visual, dimensional, and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the complaint database revealed no other similar incidents reported for difficult to position or stent damage from this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XIENCE PRIME BTK EVEROLIMUS ELUTING PERIPHERAL STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3813367
• MDR Text Key: 4405750
• Report Number: 2024168-2014-03079
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2014
• Device Catalogue Number: 1012648-38
• Device Lot Number: 1122141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SHEATH: CORDIS 7F