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

Catalog Number	1145400-38
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Myocardial Infarction (1969)
Date of Event	08/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The reported deflation issue, the reported difficulty to remove and the reported device operates differently than expected (reported translucent gap with no contrast noted in the center of the balloon) were unable to be replicated in a testing environment due to the condition of the returned device.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 reported patient effects of myocardial infarction and atrial arrhythmias are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the patient presented with an st elevated myocardial infarction (stemi) and a thrombosed proximal right coronary artery (rca)).The culprit vessel (rca) was treated with successful advancement (via femoral access) and deployment of a 4.0x38mm otw xience alpine drug-eluting stent (des).When deploying the stent, a translucent gap (with no contrast) was noted in the center of the balloon, but inflation and deployment were completed without difficulty.During an attempt to then deflate the stent delivery system (sds) balloon using an indeflator, the balloon would not deflate at all and was unable to be retracted from the deployed stent.The guide catheter was pushed forward to the edge of the stent, then multiple attempts were made to puncture the balloon using both ends of various unspecified guide wires, but the balloon was unable to be punctured after attempting for 30 minutes.Gentle, consistent force was then applied to the sds and the inflated balloon was able to be withdrawn from the stent (with no damage to the stent) and the balloon was wedged back into the guide catheter.The inflated balloon and guide catheter were withdrawn from the anatomy as a single unit, without further issue.During the procedure, the patient stemi was prolonged and the patient experienced atrial fibrillation (a-fib) due to rca obstruction of distal flow from the inability to deflate the balloon for 30 minutes.The patient was defibrillated for the a-fib.The stemi self-resolved upon withdrawal of the sds with guide catheter.The procedure was considered completed.The patient is in stable condition with no adverse sequelae.No additional information was provided.

• Brand Name: XIENCE ALPINE OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6832240
• Report Number: 2024168-2017-07122
• Device Sequence Number: 787833
• Product Code: NIQ
• UDI-Device Identifier: 08717648200380
• UDI-Public: 08717648200380
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 1145400-38
• Device Lot Number: 6012141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: D11: INFLATION: INDEFLATOR
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 48 YR