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 Detachment Of Device Component (1104); Kinked (1339); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual inspection was performed on the returned device.The reported kink was able to be confirmed.In addition, the returned device was separated 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 similar incidents from this lot.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling.

Event Description

It was reported that the xience btk tried to pass to the lesion after pre-dilatation in a tortuous anterior tibial and the stent catheter bent during the advancement across the popliteal and origin of anterior tibial.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.The returned device was returned bent but also separated and torn.

• 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 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6602981
• MDR Text Key: 76403519
• Report Number: 2024168-2017-04641
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648178900
• UDI-Public: (01)08717648178900(17)190110(10)7010441
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2019
• Device Catalogue Number: 1012648-38
• Device Lot Number: 7010441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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