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

Catalog Number	1125300-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the stent delivery catheter was returned for analysis.The reported balloon material rupture was unable to be confirmed; however, there was a noted tear in the shaft.The reported difficult to deploy was unable to be replicated in a testing environment as it was based on operational circumstances.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.As there was no report of any leak in the catheter noted during preparation for use the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the device was advanced interaction with the mildly tortuous, heavily calcified and 90% stenosed anatomy and/or interaction with other devices resulted in the torn shaft thus resulting in the reported rupture and the reported difficulty to deploy as the compromised device was inflated.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 procedure was to treat a mildly tortuous and heavily calcified, 90% stenosed, de novo lesion in the right coronary artery.A 3.0x28 mm xience alpine stent delivery system (sds) was advanced in the patient anatomy; however, during the first inflation attempt the balloon ruptured before reaching 12 atmospheres (atm).The stent was able to be implanted, but was not fully expanded.The sds was removed from the patient anatomy and a non-abbott balloon dilatation catheter was used to post-dilate the 3.0x28 mm xience alpine stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 6298853
• Report Number: 2024168-2017-00917
• Device Sequence Number: 943403
• Product Code: NIQ
• UDI-Device Identifier: 08717648199370
• UDI-Public: (01)08717648199370(17)190524(10)6051841
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2017

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: 05/24/2019
• Device Catalogue Number: 1125300-28
• Device Lot Number: 6051841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 02/02/2017
• 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: GUIDE WIRE: SION BLUE
• Outcome Attributed to Adverse Event: Required Intervention