MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 09/01/2014

Event Type  Death  

Manufacturer Narrative

Mean age, majority sex.The scaffold was implanted and will not return for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The absorb device was not commercially available in the u.S; however, it was similar to a device sold in the u.S.The additional adverse events referenced in the article are filed under a separate medwatch report number.

Event Description

It was reported through a research article that the absorb scaffold may be related to death.Specific patient information is documented as unknown.Details provided in the article titled: " three-year clinical outcomes with the absorb bioresorbable vascular scaffold in real life: insights from the (b)(6) registry¿.

Manufacturer Narrative

A2: mean age, a3: majority sex, b2, b3, c4, d6: estimated, d4: the udi# is unknown because the part and lot numbers were not provided.The absorb device was not commercially available in the u.S; however, it was similar to a device sold in the u.S.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A conclusive cause for the difficulties listed cannot be determined based on the limited information available.The patient effect of death listed is consistent with the product risk profile and are therefore expected.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11041419
• MDR Text Key: 222515474
• Report Number: 2024168-2020-10727
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR