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

Catalog Number 1500350-28

Device Problems Failure to Fold (1255); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide catheter: 5 fr kimny, sheath: 5f.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The xience sierra 3.5 x 15mm referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat lesions located in the left anterior descending artery distal to proximal that were non calcified, non tortuous and 90% stenosed.After the xience sierra 3.5 x 28 mm stent was implanted, the balloon deflated properly.There was resistance felt during removal of the stent delivery system (sds) into the guiding catheter.When the sds was removed from the patient, it was observed that the balloon did not deflate properly, however, it was confirmed that before removal attempt was made that the balloon was fully deflated.During treatment of the other vessel in the same patient, this same issue happened again with the xience sierra 3.5 x 15mm stent delivery system.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.The patient had a good outcome.No additional information was provided.

Manufacturer Narrative

(b)(4).The hi-torque balance middleweight guide wire referenced is filed under a separate medwatch report number.(b)(6).Evaluation summary: the device was returned for analysis.The reported difficulty to remove was unable to be replicated in a testing environment due to the condition of the returned device.The reported folded balloon was unable to be 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 other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The reported folded balloon was unable to be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed medwatch report, a hi-torque balance middleweight universal guide wire was returned frozen inside the xience sierra 3.5 x 28 mm stent delivery system (sds).The guiding catheter, stent delivery system and guide wire were all removed together as a single unit because it was impossible to retrieve the sds into the guiding catheter.No additional information was provided.

• 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: 7733136
• MDR Text Key: 115527586
• Report Number: 2024168-2018-05875
• 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: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Catalogue Number: 1500350-28
• Device Lot Number: 8052441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: HI-TORQUE BALANCE MIDDLEWEIGHT