MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235250-28
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The additional 2.5 x 28 mm absorb gt1 scaffold referenced is being filed under a separate manufacturer report number.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effect of dissection, as listed in the absorb gt1 instructions for use (ifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure on (b)(6) 2016 was to treat the distal and proximal right coronary artery.Two 2.5 x 28 mm absorb gt1 scaffolds were deployed.As post-dilatation was done in the mid section of the distally deployed scaffold a perforation occurred.Another non-compliant (nc) balloon was used to post-dilate the mid part with good results.While removing the nc balloon catheter a dissection occurred in the proximally deployed scaffold.A 2.75 x 18 mm xience v stent was implanted to cover the dissection.The final outcome was good.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6216636
• Report Number: 2024168-2016-09422
• Device Sequence Number: 13630889
• Product Code: PNY
• UDI-Device Identifier: 08717648212987
• UDI-Public: (01)08717648212987(17)180410(10)6101361
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2018
• Device Catalogue Number: 1235250-28
• Device Lot Number: 6101361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 12/30/2016
• 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: OTHER: 2.5 X 28 MM ABSORB GT1 SCAFFOLD
• Outcome Attributed to Adverse Event: Required Intervention