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

Catalog Number	1235350-23
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual inspections were performed on the returned device.The reported separation was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported separation appears to be related to the operation context.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during unpackaging, when pulling a 3.5x23 absorb bioresorbable vascular scaffold (bvs) system from its dispenser hoop packaging without difficulty, the distal shaft separated at the proximal to distal junction area.The device was not used in the patient and there was no occurrence of a clinically significant delay.A new absorb was unpackaged without issue and was used to complete the procedure.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: 6296639
• Report Number: 2024168-2017-00878
• Device Sequence Number: 310534
• Product Code: PNY
• UDI-Device Identifier: 08717648213137
• UDI-Public: (01)08717648213137(17)170808(10)6080961
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2017
• Device Catalogue Number: 1235350-23
• Device Lot Number: 6080961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• 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